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Official Title

A Phase 1/2, First-in-Human, Open-Label, Dose Escalation Study of Talquetamab, a Humanized GPRC5D x CD3 Bispecific Antibody, in Subjects With Relapsed or Refractory Multiple Myeloma

Phase
Phase 2
Sponsor
Janssen Research & Development, LLC
Enrollment
510
Timeline
Feb 2021 → Mar 2029
About This Study

The purpose of this study is to evaluate the efficacy and safety of talquetamab in participants with relapsed or refractory multiple myeloma at the recommended Phase 2 dose(s) (RP2Ds) (Part 3).

Eligibility Criteria

Inclusion Criteria

  • 1Documented initial diagnosis of multiple myeloma according to international myeloma working group (IMWG) diagnostic criteria
  • 2Part 3: Measurable disease cohort A, cohort B, cohort C and cohort D: multiple myeloma must be measurable by central laboratory assessment; Cohort E: Multiple myeloma must be measurable by local laboratory assessment
  • 3Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
  • 4Women of childbearing potential must have a negative pregnancy test at screening and prior to the first dose of study drug using a highly sensitive pregnancy test either serum (beta human chorionic gonadotropin \[hCG\]) or urine
  • 5Willing and able to adhere to the prohibitions and restrictions specified in this protocol

Exclusion Criteria

  • 1Part 3 only: Cohort A and Cohort C only: exposed to a CAR-T or T cell redirection therapy at any time. Cohort B, Cohort D and Cohort E: T cell redirection therapy within 3 months
  • 2Toxicities from previous anticancer therapies should have resolved to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy
  • 3Received a cumulative dose of corticosteroids equivalent to \>= 140 milligram (mg) of prednisone within the 14-day period before the first dose of study drug (does not include pretreatment medication)
  • 4Stroke or seizure within 6 months prior to signing the informed consent form (ICF)

Locations

77 sites participating in this study

Emory University Winship Cancer Institute

Atlanta, Georgia 30322

Recruiting

University of Alabama Birmingham

Birmingham, Alabama 35294

Recruiting

University of Arkansas for Medical Sciences

Little Rock, Arkansas 72205

Recruiting
Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →